Status:
RECRUITING
Prophylactic Antibiotic Treatment in Hemodialysis
Lead Sponsor:
Zealand University Hospital
Conditions:
Hemodialysis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the efficacy of prophylactic antibiotic treatment on blood stream infections and severe culture negative infections, in patients on newly started hemodialysis(HD...
Detailed Description
After being informed about the study and potential risks all eligible patients, giving written informed consent will be included in the study. At week 0 patients will be randomized in a single blinded...
Eligibility Criteria
Inclusion
- End Stage Kidney Disease (ESKD) patients who receive an uncuffed or cuffed CVC for expected chronic HD, regardless of previous ESKD treatment modality (PD or KTX) and hemodialysis access (AV-fistula or AV-graft))
- ≥18 years
- Ability to understand the study background, risk and benefit of treatment and to give written informed consent
Exclusion
- Unable to give informed consent
- Known intolerance to beta-lactam antibiotics and clindamycin
- Active infection treated with antibiotics
- Breastfeeding
- Pregnancy. In women of childbearing age, an approved birth control must be ensured at least 1 month before and during all the 6 months of antibiotic/placebo treatment.
- Patients may be rescreened later i.e. within a time period of one month from start of HD, if exclusion criteria are reversible.
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT05248620
Start Date
February 14 2022
End Date
May 1 2029
Last Update
January 30 2024
Active Locations (7)
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1
Rigshospitalet
Copenhagen, Capital Region, Denmark, 2100
2
Herlev-Gentofte Hospital
Copenhagen, Capital Region, Denmark, 2730
3
North Zealand Hospital Hillerød
Hillerød, Capital Region, Denmark, 3400
4
Aarhus University Hospital
Aarhus, Middle Region, Denmark, 8200